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The FDA has cleared Janssen and Medivir’s hepatitis C drug Olysio to be used in combination with Sovaldi, making it the latest drug to be paired up with Gilead Sciences’ blockbuster product. Read More
A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this week. Read More
The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral. Read More
Manufacturers don’t appear to be waiting for FDA guidance to meet a Jan. 1 deadline of the new track-and-trace law, and instead have begun implementing an electronic version of a widely used tracking form to satisfy the law’s requirements. Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More
Mylan said yesterday it has launched a generic version of Warner Chilcott’s oral contraceptive Loestrin 24 Fe in the U.S., following final FDA approval. Read More
Biosimilars are expected to account for roughly 4 percent of all biologics sales over the next 10 years, saving the U.S. healthcare system an estimated average of $44.2 billion, according to new research that forecasts significantly lower savings from the products than another widely cited study. Read More
The number of patent lawsuits filed over generic drug challenges has spiked this year, a development that coincides with the widely anticipated “patent cliff” of many brand drugs losing protection. Read More
The entire class of prescription and over-the-counter proton pump inhibitors do not require a boxed warning, but some prescription PPIs should contain a medication guide, the FDA said in response to a long-waiting citizen petition. Read More
The FDA is asking drugmakers to use the data universal numbering system (DUNS) to register their manufacturing facilities in the U.S. and abroad. Read More
An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More
The Republican landslide in Tuesday’s midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain. Read More